|
Device | ARCTIC FRONT FAMILY CARDIAC CRYOABLATION CATHETERS |
Generic Name | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Applicant | Medtronic CryoCath LP 8200 CORAL SEA STREET MS MVS46 MOUNDS VIEW, MN 55112 |
PMA Number | P100010 |
Supplement Number | S057 |
Date Received | 06/07/2016 |
Decision Date | 07/07/2016 |
Product Code |
OAE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Acceptance of new impedance criteria for the fluid detection circuit and modified related in-process and final inspection test equipment software. |